At a glance
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Optimal Dose of Combination of Rocuronium and Cisatracurium: A Randomized Double-blinded Clinical Trial
In Brief
A clinical study evaluating 10% reduction of combination of Esmeron® and Nimbex® and 20% reduction of combination of Esmeron® and Nimbex® for Chronic Otitis Media and Anesthesia. Completed, enrolled 81 participants.
Detailed Summary
BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The investigators studied whether the prediction is possible to have a sufficient effect of reducing the dose when combining the two neuromuscular blocking agents through monitoring neuromuscular relaxation during surgery. METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose (ED)95 rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each study drug was administrated to the patient and timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the ulnar nerve was used as setting of 2 Hz per 12 sec. The investigators checked time to TOF ratio=0 (Onset), time to 1st TOF ratio\>25% (Duration 25%) and TOF 25-75% (recovery index) under total i.v. anesthesia (TIVA). One way ANOVA was used for statistical analysis (α=0.05, β=0.2).
Study Details
Timeline
Interventions
Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.